Events

Recall of Device Recall Digital Diagnost, stationary radiographic system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67859
  • Event Risk Class
    Class 2
  • Event Number
    Z-1503-2014
  • Event Initiated Date
    2014-03-17
  • Event Date Posted
    2014-04-24
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126536
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Solid stae x-ray (flat panel/digital imager) - Product Code MBQ
  • Reason
    The footboard of patient support for stitching can be fixed in upper position. when the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held.
  • Action
    On March 17, 2014, consignees were notified of the recall via letter. The letter explains what the issue is, actions firms can take to avoid or minimize the occurrence of the issue, and the actions planned by Philips to correct the issue. For further information or support concerning this issue, please contact your local Philips Representative. 1-800-722-9377

Device

Device Recall Digital Diagnost, stationary radiographic system
  • Model / Serial
    Units distributed from November 2006 through March 2014.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide: US: AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, WY / Worldwide including Canada & Mexico
  • Product Description
    Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • Manufacturer Address
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA